Hemiarthroplasty Compared to Total Hip Arthroplasty for Displaced Femoral Neck Fractures in the Elderly-elderly

Femoral Neck Fractures Clinical Trial

— HOPE  

Official title:

Hemiarthroplasty Compared to Total Hip Arthroplasty for Displaced Femoral Neck Fractures in the Elderly-elderly. A Randomized Controlled Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02246335
• Other study ID #: HOPE
• Status: Active, not recruiting
• Phase: N/A
• First received: September 18, 2014
• Last updated: August 29, 2016
• Start date: October 2009
• Est. completion date: October 2020

Study information

• Verified date: August 2016
• Source: Danderyd Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

Total Hip Arthroplasty is equal to or better than Hemiarthroplasty in the treatment of displaced femoral neck fractures in the elderly-elderly

Description:

Total Hip Arthroplasty is equal to or better alternative to Hemiarthroplasty in the treatment of displaced femoral neck fractures in the elderly-elderly (patients 80 years and over).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: October 2020
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 80 Years and older

Eligibility

Inclusion Criteria:

• Acute displaced femoral neck fracture of hip (Garden classification 3-4)

• Independent walker with or without walking aides

• Patient willing to participate in the study and give written consent.

Exclusion Criteria:

• Fracture older than 36 hours before admission

• Osteoarthritis in the fractured hip

• Rheumatoid arthritis in the fractured hip

• Pathological fractures

• Contraindication for hip arthroplasty surgery

• Not suitable for inclusion for other reasons e.g. substance abuse

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Fractures, Bone

Intervention

Device:
• Cemented total hip arthroplasty

• Cemented hemiarthroplasty

Locations

Country	Name	City	State
Sweden	Orthopaedic department, Danderyd Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Danderyd Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harris hip score	The hip specific outcome score Harris hip score at 2 years will be the main outcome variable	2 years	No
Secondary	EQ-5D	Health-related quality of life at 2 years	2 years	No
Secondary	EQ-5D	Health-related quality of life at 4 years	4 years	No
Secondary	EQ-5D	Health-related quality of life at 6 years	6 years	No
Secondary	EQ-5D	Health-related quality of life at 10 years	10 years	No
Secondary	Adverse events	All hip related adverse events at 2 years	2 years	Yes
Secondary	Adverse events	All hip related adverse events at 4 years	4 years	Yes
Secondary	Adverse events	All hip related adverse events at 6 years	6 years	Yes
Secondary	Adverse events	All hip related adverse events at 10 years	10 years	Yes
Secondary	Harris hip score	Harris hip score at 4 years	4 years	No
Secondary	Harris hip score	Harris hip score at 6 years	6 years	No
Secondary	Harris hip score	Harris hip score at 10 years	10 years	No